Problems have long existed in maintaining an accurate accounting of tools, parts and components during complex procedures. For example, keeping accurate track of the medical devices and medications used during medical procedures has been one of the major concerns of healthcare facilities for many years. This problem is particularly costly in many ways for large sized hospitals comprising scores of operating rooms, and millions of dollars of medical device inventory. For example, errors in the dispensing, administration and prescribing of medications and medical treatments have resulted in an unacceptably large number of adverse reactions, including many deaths and permanent impairments, leading to higher insurance costs and expensive legal judgments.
Additionally, medical devices may be displaced during transfer from and to surgical processing departments, sterilization process and/or operating room procedures. Even if the medical device is brought into the medical treatment area, quite often the use of the medical device within the medical treatment area for the patient is not recorded. Consequently, these medical devices go unaccounted for in the billing process. Further, “renegade” medical devices, such as those brought into an operating room by a sales representative, may be implanted into a patient, with no such record of the device ever being in the medical facility. Worse yet, if there is a recall of the renegade medical device, it is virtually impossible to determine which patient received the device because of the gap in record keeping.
There are several computerized solutions available on the market, which provide a level of tracking of medical devices. Many systems use bar-code label scanning and/or magnetic stripe card technology to facilitate tracking of medical devices through the decontamination process; the inspection, assembly, and packaging process; and the sterilization cycle. For medical devices such as surgical instruments, these systems consider any particular set as a unit and provide a list of the instruments comprising the set.
While the cost of such bar-code labels and magnetic stripe cards is low, the amount of information that can be embedded or coded in either of these media is also relatively low, even where complex bar codes such as a 2-D bar code is employed. In addition, most bar code readers are read-only devices that can only read the information stored in the bar code and cannot store any additional information in the bar-code label.
Moreover, bar-code media require a “line-of-sight” communication path between device and reader, and magnetic stripe media require a direct or close contact communication path between device and reader at a suitable “swiping speed,” and the reliability of correct reading is about 80-90%. Repeated passes of the device in front of the bar-code reader or swipes of the card reader create delay and annoyance and/or can produce record errors. Such problems are not overcome with more complex bar codes, and can actually be exacerbated where the bar code elements are smaller in size and thus more sensitive to smudging and dirt.
Absent a network connection to a computer, prior art tracking systems do little more than to read the information stored in the bar code or magnetic stripe, and cannot detect errors therein, which is a particular disadvantage in relation to medication and medical devices wherein errors in dispensing and/or using the medication or device can have serious, if not fatal, consequences. Furthermore, prior art tracking systems do not account for the introduction of renegade medical devices into the healthcare facilities.